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Which seton works best for anal fistulas? trial cut short

NCT ID NCT05933343

Symptom relief Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two types of drainage setons—Ethibond suture and vessel loop—for treating complex anal fistulas. The goal was to see which material drains infection better, lasts longer, and improves quality of life. However, the trial was terminated early after enrolling only 2 participants, so no firm conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ethibond suture or vessel loop (drainage seton)
What this could lead to
If successful, this could show which seton material is more comfortable and effective for draining anal fistulas, potentially improving quality of life.
What could go wrong
The trial was terminated early with only 2 participants, so results are very limited. It is unclear if either material is truly better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2 people

The number who actually took part.

Started

Dec 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients aged 18 years or older of either sex who present with CAF will be included. Both cryptoglandular fistulas and fistulas secondary to inflammatory bowel disease (IBD) Exclusion Criteria: * Simple anal fistulas * Fistulas secondary to malignancy or irradiation therapy * Pregnant women * Patients with pre-existing setons

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Conditions

The condition(s) this trial relates to.

anal fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anal fistula

Contacts and locations

Locations

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.